Recall: FreeStyle InsuLinx Blood Glucose Meters Having Data Issues

Abbott announced a voluntary recall of FreeStyle InsuLinx blood glucose meters in the U.S.

At extremely high blood glucose levels of >1,024mg/dL, the FreeStyle InsuLinx meter displays and stores an incorrect test result that is 1,024mg/dL below the actual measured result. For example, at a blood glucose value of 1,066mg/dL, the meter will display and store a value of 42mg/dL (1,066mg/dL – 1,024mg/dL = 42mg/dL).

Although blood glucose levels at >1,024mg/dL are very rare, they are a serious health risk when they occur. With the meter displaying an inaccurate low result at a blood glucose level above >1,024mg/dL, there may be a delay in the identification and treatment of severe hyperglycemia, or an incorrect treatment may be given.

Customers who are using the FreeStyle InsuLinx meter are to either access a software update to resolve the issue or contact customer service at (866) 723-2697 to receive a replacement of their meter at no charge. No other Abbott blood glucose meters are affected by this issue.